ScoliosisNCT01163955
A Postural Study Comparing Sitting on the Floor Versus Sitting in a Chair While Playing Video Games.
A study testing Time to fatigue in people with Scoliosis, run by Glinn and Giordano Physical Therapy at 1 site in United States.
Trial summary
To determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Time to fatigue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- English and Spanish Speaking
Who cannot join
- Non-english or non-spanish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Postural Analysis of Children Playing Video Games Sitting on the Floor vs. Sitting in a Chair: A Randomised Controlled Trial
To determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games.
Read the detailed description
Upon completion of the parental consent form, each test subject will be instructed to flip a two-sided coin to determine the sitting position of the test subject. If the flip reveals a "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized to allow the child to rest his/her feet on the ground. If the flip reveals a "tails", the child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. Each test subject will be taken to their gaming station which will sit approximately 8 feet away from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless controller. Two gaming stations will be available with one featuring the game Lego Batman and the other featuring Lego Indiana Jones with both gaming stations testing simultaneously. The test subjects will be told they can play for 5 minutes with a Physical Therapist at each station to monitor and record the test subjects' positioning.
- Conditions
- Scoliosis
- Being tested
- Time to fatigue
- Keywords
- Posture analysis, Video gaming, Forward Head Position, Rounded Shoulder Position, Spine Posture
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time to fatigueOther
5 minutes while playing video games
| Study group | Role | What they receive |
|---|---|---|
| Sitting in a chair | Other | Sitting in a chair with back support and feet flat on the ground Receives: Other: Time to fatigue |
| Sitting on the Floor | Other | Sitting on the floor without back support, crossed leg style Receives: Other: Time to fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture Control of Head Position, Shoulder Position and Back Position
Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glinn and Giordano Physical Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willam Brian Monroe, Glinn and Giordano Physical Therapy
- Investigators
- William B Monroe, DPT, OCS, Principal investigator, Glinn and Giordano Physical TherapyErin P Pandol, MPT, OCS, Principal investigator, Glinn and Giordano Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163955
- Sponsor's protocol ID
- Protocol 10-90
- Status last verified
- Oct 2011
- First submitted
- 15 Jul 2010
- Last updated
- 2 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postural Analysis of Children Playing Video Games Sitting on the Floor vs. Sitting in a Chair: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01163955
- Acronym / sponsor ID
- Protocol 10-90
- Conditions
- Scoliosis
- Keywords
- Posture analysis, Video gaming, Forward Head Position, Rounded Shoulder Position, Spine Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Glinn and Giordano Physical TherapyUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Posted 30 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games.
Detailed description
Upon completion of the parental consent form, each test subject will be instructed to flip a two-sided coin to determine the sitting position of the test subject. If the flip reveals a "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized to allow the child to rest his/her feet on the ground. If the flip reveals a "tails", the child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. Each test subject will be taken to their gaming station which will sit approximately 8 feet away from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless controller. Two gaming stations will be available with one featuring the game Lego Batman and the other featuring Lego Indiana Jones with both gaming stations testing simultaneously. The test subjects will be told they can play for 5 minutes with a Physical Therapist at each station to monitor and record the test subjects' positioning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitting in a chair | Other | Other: Time to fatigueSitting in a chair with back support and feet flat on the ground |
| Sitting on the Floor | Other | Other: Time to fatigueSitting on the floor without back support, crossed leg style |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- English and Spanish Speaking
Key exclusion criteria (1 listed)
- Non-english or non-spanish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time to fatigue5 minutes while playing video games | Other | Sitting in a chair, Sitting on the Floor |
Primary outcome
Posture Control of Head Position, Shoulder Position and Back Position
Time frame: 5 minute
Forward Head Position (FHP), Rounded Shoulder Position (RSP), and Thoracic spine (T/s)-Lumbar spine (L/s) positions were scored. Subscale scores of 0-3 for each FHP, RSP, and T/s L/s position were obtained. Score 0 was a perfect posture score, Score 1 was 0-1 inches out of alignment. Score 2 was 1-2 inches out of alignment. Score 3 was 2-3 inches out of alignment. Subscale scores were combined for a total score with a minimum value of 0 and a maximum value of 9. 0 being a perfect posture score, 9 being the worst postural score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Monroe, DPT, OCS principal investigator
Glinn and Giordano Physical Therapy
Erin P Pandol, MPT, OCS principal investigator
Glinn and Giordano Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time to fatigue in people with Scoliosis, run by Glinn and Giordano Physical Therapy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture Control of Head Position, Shoulder Position and Back Position (time frame: 5 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.